Document OEQNDm94MzeeMdjmmB3BmK5eX

AR226-0988 has actually been processed as 8EHQ-0501-0373 but is included here in FYI-0101-1378 as well as it was received as an attachment to this FYI. A ff 3M 651 733 I HO __ til u a ib o S fflQ . O ^ O U 0373 July 24, 2000 R E C E IV E D D E C 1 8 2000 M .A . N a s h 4 5 t- H P '^ o _ 3 Document Processing Center (7407) V '-- Attn: Section 8(e) Coordinator Office of Pollution Prevention and Toxics .. USEPA ' 401 M Street, SW CERTIFIED MAIL Washington, DC 20460 - ^ ::: Q TSCA 8(E) SUBSTANTIAL RISK NOTICE ON: N-Methyl Perfluorooctanesulfonamido Ethanol Dear Sir: Cj" 3M is reporting information that shows N-Methyl Perfluorooctanesulfonamido toxicity is consistent with that of related perfluorooctanyl sulfonates previously submitted to EPA [see 8(e) dockets #373 and 374]. Enclosed is the final report from Covance Laboratory on a 13-Week Dietary Study of N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats. As expected, higher dose levels (30 and lOOppm N-MeFOSE in food) produced liver effects. The liver changes included increased liver weights, hepatocyte hypertrophy, and hepatocellular vacuolation. Lower cholesterol and triglycerides levels were also found in the high dose (lOOppm) and mid dose (30ppm) animals. Neither liver effects nor cholesterol/triglyceride changes were found in the low dose (3ppm) animals. Significantly reduced body weights were present in the high dose animals beginning at week 4 and continuing until the end of the study. Significantly reduced body weights occurred in die mid dose animals beginning at week 7 and continued until the end of the study. Weekly body weights of the low dose animals during the second half of the study were somewhat less than controls. None of the low dose weekly body weights were significantly different from controls. However, the overall body weight gain during the study (weeks 1 through 14) of the low dose animals was significantly less than the controls. & EPA-OTS 000811815O aooaiiaiso ro H c_ 0 Lr ~o CO ''~l ,j co o cO ro ro RECEIVE 4/2 ,p p ? Document Processing Center (7407) Page Two July 24, 2000 The Covance report concludes that the 3ppm dose was the no-observable adverse-effect level (NOAEL) as the minor body weight effect found at 3ppm was not correlated with any clinical chemistry or anatomic pathological changes; it was not considered to be biologically adverse. . The study report is attached. Please contact Dr. William Weppner, 651-733-6374, for further information. Sincerely, Charles Reicfr Vice President, Specialty Materials Markets Enclosures: 1. 4-Week Range-Finding Dietary Toxicity Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats (T-6314) 2. 13-Week Dietary Study with N-Methyl Perfluorooctanesulfonamido Ethanol (N-MeFOSE) in Rats (T-6314) ty /3